Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder (NCT06577636) | Clinical Trial Compass
RecruitingPhase 2
Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
United States42 participantsStarted 2025-07-21
Plain-language summary
The goal of this study is to test whether anesthesia-induced dreaming can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) double-blind, randomized controlled trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving deep sedation leading to loss of responsiveness, designed to elicit dream reports upon emergence (Dream Protocol), and/or (2) light sedation without loss of responsiveness, designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) (Non-Dream Protocol). The investigators will then investigate whether the deep-sedation Dream Condition is associated with a larger reduction in PTSD symptoms than the light-sedation Non-Dream Condition.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female, 18 to 70 years of age
✓. Able to read, understand, and provide written, dated informed consent prior to screening.
✓. Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Structured Clinical Interview for DSM Disorders (SCID).
✓. Meet the threshold of CAPS-5 score of \>20 during screening.
✓. In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II.
✓. If female, a status of non-childbearing potential or use of an acceptable form of birth control
✓. Body mass index between 17-35 kg/m2.
Exclusion criteria
✕. Female who is pregnant or breastfeeding.
What they're measuring
1
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
. Total CAPS-5 score ≤20 at either the screening.
✕. Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (\>12 months) time frames.
✕. Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more)
✕. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
✕. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
✕. Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
✕. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.